Cleared Traditional

K830950 - VASCULAR PRODUCTS IMPLANTABLE PACING

K830950 is an FDA 510(k) clearance for VASCULAR PRODUCTS IMPLANTABLE PACING, manufactured by Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K830950 · Oscor, Inc. · Cardiovascular device
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Apr 1983
Decision
24d
Days
Class 3
Risk

K830950 is an FDA 510(k) clearance for the VASCULAR PRODUCTS IMPLANTABLE PACING. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Oscor, Inc. devices

FDA 510(k) Submission Details - K830950

510(k) Number K830950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1983
Decision Date April 18, 1983
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K830950.
MODEL MF..D & MX..D PACEMAKER LEADS
K823898 · Oscor, Inc. · Apr 1983
IMPLANTABLE PACING LEAD CCS MODEL SV-101
K830828 · Cardiac Control Systems, Inc. · Apr 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · Intermedics, Inc. · Apr 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890 · Oscor, Inc. · Mar 1983
MODEL KY PACEMAKER LEAD - VARIOUS
K823891 · Oscor, Inc. · Mar 1983
PACING LEAD #PMA F 860
K830457 · Ela Medical, Inc. · Mar 1983